Surgical reservoir for implantation beneath the skin



arch 21, 1967 R. R. SCHULTE 3,31%051 SURGICAL RESERVOIR FOR IMPLANTATIONBENEATH THE SKIN Filed Dec. 10, 1963 SCALP-// rfmaw United States Patent3,310,051 SURGICAL RESERVGIR FOR Iii PLANTATION BENEATH THE SKIN RudolfR. Schulte, 3328 Calle Fresno, Santa Barbara, Calif. 93185 Filed Dec.10, 1963, Ser. No. 329,443 2 Claims. (Cl. 128-216) This inventionrelates to a surgical implant which provides a reservoir locatedconveniently to the skin of a person which may be utilized to introduce,withdraw, or mix fluids in regions located farther inside the body.

There are numerous instances Where repetitive samplings of body fluidsneed to be made, or in which repetitive introductions or medication mustbe made to interior regions. An example i the repetitive sampling ofcerebro-spinal fluid, and vthe introduction of medication thereto, suchas in the treatment of cryptococcal meningitis or tubercular meningitis.Medication for these diseases is often only marginally effective ifgiven intravenously, because in order to supply the concentration neededat the situs of the ailment, the total dosage in the body would have tobe too high. In fact, these diseases have been unmanageable withintravenous injections principally for this reason. However, if themedications are injected at the situs of the ailment, the localconcentration can be made high enough to be effective, and the diseasesmay be controlled, even though the total dosage in the body isrelatively low.

A concurrent problem associated with the foregoing is that concentrationlevels need to be maintained at the situs over a protracted period oftime. To make repeated injections by means of repetitive punctures isobviously undesirable, and in many regions of the body soon becomesimpossible. One reason is that fibrosis develops around t-he multipleneedle tracks and renders access increasingly diflicult, particularly inthe brain. Furthermore, repeated punctures of the brain are inherentlyundesirable. While the examples given in this specification relate totreatment of regions within the skull, clearly the same criteria applyto ailments in other regions of the body.

It is an object of this invention to provide a device which, onceinstalled, gives continuous access to internal regions of the bodywithout requiring additional needle penetrations into these regions.Instead, a tubular portion of the device remains in the body and extendsto the affected area where it serves as a continuously-available conduitplaced there but once. Thereafter, a syringe or other device need onlybe placed in fluid communication with this conduit to inject, Withdrawor mix fluids in the interior region.

Still another object of the invention is to provide a mixing or flushingreservoir into which fluids may readily be injected or from which theymay readily be withdrawn. An optional object is to provide such areservoir which may also serve to provide surge-generatiug means offlush and mix fluids in it and in the region under treatment.

A device according to this invention comprises a tube having a centralpassage, the tube being adapted to be inserted in to the body so thatits passage communicates with a selected region therein. A capsule isadapted to be connected to this tube and to be placed beneath the skinof the body. This capsule comprises an enclosure which has an internalperiphery and a first and second wall, these walls facing each otherinside the capsule. The wall next to the skin is tolerant to, andself-sealing after, needle puncture. One of the walls has a passagetherethrough in fluid communication with the passage through the tube.

According to a preferred but optional feature of the invention, one ofthe walls is flexible and palpable through the skin by force exerted bythe hand. The material of the flexible wall is flexible enough to bemoved toward the other wall and thereby reduce the volume of the capsuleand also sufficiently springy to return to its normal unstressedcondition, thereby providing for pumping means to create bi-directionalflow in the passages for mixing purposes.

The above and other features of this invention will be fully understoodfrom the following detailed description and the accompanying drawings inwhich:

FIG. 1 is a cross-section of a portion of a skull, showing the device ofthe invention, partly in cutaway crosssection and in its normal,unstressed condition;

FIG. 2 is a top view of the invention, partly in cutaway cross-section;

FIG. 3 is a bottom view of the device taken at line 33 of FIG. 1; and

FIG. 4 is a fragmentary cross-section of a portion of FIG. 1, showingthe device in another of its conditions.

FIG. 1 illustrates a skull 10, showing the scalp 11 and the bone 12 ofthe skull surrounding the brain 13. The drawing of the anotomicalportions is simplified because these form no portion of the presentinvention. It will be noted that the device is installed within a burrhole 14 having an internal wall 15 in the bone of the skull, and is heldbeneath the skin of the scalp by means of a sutured slit 16.

The reservoir elements 20 comprising the invention includes a tube 21having a central passage 22 and a closed end 23. Perforations 24 throughthe wall provide for fluid communication between the passage and theoutside of the tube. The tube is connected to a capsule 25 by means of aconnector 26, which connector is attached to a passage extension 27which has a passage 28 that enters the capsule itself through one wallthereof. The capsule has a boss 29 which fits within burr hole 14 andprovides for lateral restraint of the device. The capsule outward of theboss rests on the skull so as to give longitudinal restraint.

The capsule is a continuou enclosure and includes a circumferentialperiphery defined by circumferential edge 30. First and second interiorwalls 31, 32 are provided on opposite sides of the periphery. The firstwall lies closer to the skull, and includes an interior crown 33 whichsurrounds the opening 34 of passage 28 into the interior of the capsule.The crown has a plurality of notches 35 formed therein.

Second wall 32 is generally domed and has a central section which isthicker than the edges. This wall is flexible and, as best shown in FIG.4, is adapted to be palpated by finger pressure through the scalp tomove it toward the first wall, thereby reducing the volume of thecapsule. In order to prevent the first and second walls from adhering toeach other and closing the passages, the crown is provided to hold themapart. However, the notches provide for fluid flow past the crown to thepassage even when the second wall is pressed against the crown.

The entire structure is, of course, made of material which is compatiblewith the human tissue with which it comes in contact. A convenientsubstance is silicone rubber manufactured by Dow Corning Company, ofMidland, Mich. The thickness of the second wall is selected such that itis springy enough to restore itself to its normal, unstressed conditionshown in FIG. 1, and yet sufliciently flexible that it can be deflectedto the configuration shown in FIG. 4. It is also tolerant to repetitiveneedle punctures (with a resonable number), because, as best shown inFIG. 1, material may be in- 3 jected from a hypodermic syringe 36 bypuncturing the scalp and the second wall with the needle. When theneedle is withdrawn, the material of the second wall will seal theopening made by the needle.

The use of the device should be evident from the foregoing. If it isdesired either to withdraw fluid from region 37 within the brain or tointroduce medication thereto, the tube will be forced into this regionby means well known in the surgical arts. Once in place, this tube isconnected to the capsule, and the capsule is placed in position asshown, and the scalp sutured over the capsule. The capsule is filledwith fluid, which, after a time, will be identical with fluid in theregion under study, particularly if the device is pumped for a while,either by depressing the second wall or by pumping with a syringe. Thefluid may be withdrawn for sampling by a hypodermic syringe. Also,medication may be introduced to the region by a syringe as shown, mixingbeing attained either by depressing the second wall or by pumping withthe syringe.

It will thereby be seen that this device provides a reservoir of fluidwhich in effect is an extension of a region under treatment or study.Only one puncture of the brain or other region is necessary because thetube remains in place for sensible periods of time to provide acontinuously-available conduit to the region, and the dome i availablefor introduction and withdrawal of material even were the second wall tobe too stifl to flex. On the other hand, should the device be madeflexible enough for this purpose, then even better results may beattained as a result of the more complete bi-directional flow attainablethereby.

This invention is not to be limited by the embodiment shown in thedrawings and described in the description which is given by way ofexample and not of limitation, but only in accordance with the scope ofthe appended claims.

I claim:

1. A reservoir element for implantation in a human being comprising: atube having a central passage and adapted to be inserted into the bodyso that its passage communicates with a selected region to be treated;and

a capsule of a size to be placed beneath the skin so as to rest betweenthe skin and the bony structure of the body, said capsule comprising anenvelope having an in ner cavity bounded by a first and a second wall,the first wall being adapted to lay on surface to surface contact withsaid bony structure, the second wall being domed and springily flexibleso as to be deformable and movable toward the first wall so as to reducethe volume of the cavity as the result of external force thereon, and toreturn to its dome shape of its own accord when the force is removed,there being a passage through said first wall connected to the passagein the tube, and a crown formed inside the cavity around the entrance ofthe passage thereinto, said cr-own having notches thereon, whereby thewalls are prevented from adhering to each other and also from shuttingoff flow through the passage when the capsule is compressed, the secondwall being made of material which permits puncture by a needle and isself-sealing after the needle is withdrawn.

2. A reservoir element according to claim 1 in which a boss surroundsthe capsule passage on the outside surface of the first wall, whereby tofit in a hole in the said bony structure and thereby to provide lateralpositioning support for the capsule.

References Cited by the Examiner UNITED STATES PATENTS 513,238 1/1894Lalonde 128-126 3,021,842 2/1962 Flood 128215 3,111,125 11/1963 Schulte128350 3,144,866 8/1964 Ellis 128232 3,154,074 10/1964 Harrison l28232FOREIGN PATENTS 790,220 2/ 1958 Great Britain.

OTHER REFERENCES Lancet, vol 2 (63), No. 7315, Nov. 9, 1963, pp. 983-84.

RICHARD A. GAUDET, Primary Examiner.

DALTON L, TRULUCK, Examiner.

1. A RESERVOIR ELEMENT FOR IMPLANTATION IN A HUMAN BEING COMPRISING: ATUBE HAVING A CENTRAL PASSAGE AND ADAPTED TO BE INSERTED INTO THE BODYSO THAT ITS PASSAGE COMMUNICATES WITH A SELECTED REGION TO BE TREATED;AND A CAPSULE OF A SIZE TO BE PLACED BENEATH THE SKIN SO AS TO RESTBETWEEN THE SKIN AND THE BONY STRUCTURE OF THE BODY, SAID CAPSULECOMPRISING AN ENVELOPE HAVING AN INNER CAVITY BOUNDED BY A FIRST AND ASECOND WALL, THE FIRST WALL BEING ADAPTED TO LAY ON SURFACE TO SURFACECONTACT WITH SAID BONY STRUCTURE, THE SECOND WALL BEING DOMED ANDSPRINGILY FLEXIBLE SO AS TO BE DEFORMABLE AND MOVABLE TOWARD THE FIRSTWALL SO AS TO BE DEFORMABLE AND OF THE CAVITY AS THE RESULT OF EXTERNALFORCE THEREON, AND TO RETURN TO ITS DOME SHAPE OF ITS OWN ACCORD WHENTHE FORCE IS REMOVED, THERE BEING A PASSAGE THROUGH SAID FIRST WALLCONNECTED TO THE PASSAGE IN THE TUBE, AND A CROWN FORMED INSIDE THECAVITY AROUND THE ENTRANCE OF THE PASSAGE THEREINTO, SAID CROWN HAVINGNOTCHES THEREON, WHEREBY THE WALLS ARE PREVENTED FROM ADHERING TO EACHOTHER AND ALSO FROM SHUTTING OFF FLOW THROUGH THE PASSAGE WHEN THECAPSULE IS COMPRESSED, THE SECOND WALL BEING MADE OF MATERIAL WHICHPERMITS PUNCTURE BY A NEEDLE AND IS SELF-SEALING AFTER THE NEEDLE ISWITHDRAWN.